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Real-world experience with brolucizumab in neovascular age-related macular degeneration over 2 years: the REBA extension study

  • Retinal Disorders
  • Published:
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Abstract

Background

To determine long-term efficacy and safety of intravitreal brolucizumab therapy for neovascular age-related macular degeneration (nAMD) in the real-world setting.

Methods

Retrospective, observational, multicentric study and an extension of the REBA study (Real-world Experience with Brolucizumab in nAMD) to 24 months. The study entailed follow-up of 91 consecutive eyes (67 patients) with nAMD who received brolucizumab therapy and completed 24 months of follow-up. Both treatment-naïve and switch therapy patients were included. All relevant data were collected. The primary outcome measure was changed in best-corrected visual acuity (BCVA) over time. Secondary outcome measures included change in central subfield thickness (CST) and complications.

Results

The mean (SD) baseline BCVA was 48.4 (3.5) letters and 36.2 (7.1) letters in treatment-naïve group and switch therapy group, respectively. BCVA gain was + 9.2 (3.7) letters (p = 0.01) and + 7.7 (3.4) letters (p = 0.011), respectively. The change in mean (SD) CST has shown a significant decrease in retinal thickness in treatment-naïve group (from 432.5 (68.4) to 283.0 (51.3) µm; p = 0.018) and in switch therapy group (from 452.5 (40.5) to 271.0 (43.4) µm; p = 0.011) group. One switch patient developed vascular occlusion and another a macular hole after the fifth brolucizumab injection as reported in the primary study. Both patients recovered uneventfully. Three patients demonstrated reversible intraocular inflammation between months 10 and 24.

Conclusion

Patients showed a significant anatomical and functional response to brolucizumab therapy in the real world, regardless of prior treatment status, until the end of the follow-up period. Overall, 5 significant untoward events were noted.

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Data availability

All data are available upon request to the corresponding author.

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Authors and Affiliations

  1. Alphavision Augenarztpraxis, 27568, Bremerhaven, Germany

    Alper Bilgic & Aditya Sudhalkar

  2. MS Sudhalkar Medical Research Foundation, Baroda, 390001, India

    Alper Bilgic & Aditya Sudhalkar

  3. Service d’Ophtalmologie, Centre Hospitalier Universitaire de La Croix-Rousse, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, 69004, Lyon, France

    Laurent Kodjikian & Thibaud Mathis

  4. UMR-CNRS 5510, MATEIS, INSA, Université Lyon 1, Villeurbane, 69100, Lyon, France

    Laurent Kodjikian & Thibaud Mathis

  5. Department of Ophthalmology, Otago University, Dunedin, 9016, New Zealand

    Francesc March de Ribot

  6. Department of Ophthalmology, University of Hamburg, 20246, Hamburg, Germany

    Martin S. Spitzer

  7. Raghudeep Eye Hospital, Ahmedabad, India

    Vaishali Vasavada

  8. Ophthalmology Department, School of Medicine, University Hospital “Dr. Jose Eleuterio Gonzalez, Universidad Autónoma de Nuevo León, 64460, Monterrey, Mexico

    Jesus Hernan Gonzalez-Cortes

  9. Retina Institute of Bengal, Siliguri, India

    Somnath Chakraborty

Authors
  1. Alper Bilgic
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  2. Laurent Kodjikian
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Contributions

Conceptualization: AB, LK, AS, MS, and TM; methodology: AB, LK, FMDR, AS, MS, JHGC, and TM; validation: AB, LK, FMDR, VV, JHGC, MS, AS, and TM; formal analysis: AB, LK, FMDR, VV, JHGC, AS, and TM; investigation: AB, LK, VV, AS, and TM; writing—original draft preparation: AB, AS, MS, JHGC, MS, VV, and TM; writing—review and editing: AB, LK, FMDR, VV, JHGC, and AS; supervision: LK, TM, and MS. All authors have read and agreed to the published version of the manuscript.

Corresponding authors

Correspondence to Alper Bilgic or Aditya Sudhalkar.

Ethics declarations

Ethics approval

This study complied with the tenets of the Declaration of Helsinski and was approved by an international review board (Ethics Committee of the French Society of Ophthalmology, IRB 00008855 Société Française d’Ophtalmologie IRB#1). Patients gave their informed consent to participate in the study.

Consent to participate

Informed consent was obtained from all subjects involved in the study.

Conflict of interest

Laurent Kodjikian is consultant for Allergan/Abbvie, Bayer, Horus, Novartis, Roche, and Théa. Martin S Spitzer is consultant for Apellis, Abbvie, Bayer, Neurogene, and Roche. Thibaud Mathis is consultant for Allergan/Abbvie, Bayer, GSK, Horus, and Novartis. Other authors have no conflict of interest to declare.

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Bilgic, A., Kodjikian, L., de Ribot, F.M. et al. Real-world experience with brolucizumab in neovascular age-related macular degeneration over 2 years: the REBA extension study. Graefes Arch Clin Exp Ophthalmol 262, 1161–1167 (2024). https://doi.org/10.1007/s00417-023-06329-1

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  • DOI: https://doi.org/10.1007/s00417-023-06329-1

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